OHRP Research Community Forum- We Have to Speak Up, Ken Gordon

It is my pleasure to also welcome you to the OHRP Research Community Forum, and what is now our annual IRB conference. We hope to be able to confirm the date for next year’s IRB in the next few days.

The mission of NWABR is to promote the public’s trust in biomedical research and its ethical conduct. The first part of our Mission focuses on the public’s trust. All of the research shows that members of the public have less and less trust in institutions and in biomedical research.

According to Gallup, the trust levels for biomedical and animal based research, especially among young people, are near all-time lows. There are similar trends about trust is science, Trust in governments and trust in institutions.

As a non-scientist, I value how smart all of you are. I value research. I value learning. However, in the broader community the anti-science movement is swaying public opinion in areas as diverse as climate change, evolution and even when it comes to basic medical procedures such as childhood vaccinations.

This is an extremely worrying trend for the community in general and for the biomedical research field in particular. Every single person in this room has benefited from the sea change in medical practice that has occurred over the last century – with much of that sea change being driven by biomedical research.

If we lose the public’s trust in our work then our ability to continue to drive change will come to a shuddering stop.

But I want to stop talking in generalities and come back to the theme of this OHRP Community Research Forum – Managing Under Pressure.

As a group who really cares about research how would it feel if you woke up to see a headline like this in the front page of the Seattle Times. “Harborview to test drug on the unconscious without consent”.

For those of you who have not read the article, my very simple summary is that Harborview (one of the NW’s largest public trauma hospitals) is one partner in a larger study and they wish to test a drug that has been used to help control bleeding in other parts of our bodies, to see whether it is effective to control inter-cranial bleeding that has occurred due to a head trauma.

The extent of the head trauma means that patients are likely unconscious or very confused, so Harborview received IRB approval to undertake non-consent trials.

I don’t know this for sure, but I guess that the release of the information about this trial to the Seattle Times was undertaken as a component of an IRB requirement that Harborview has to let the community in general, and target communities in particular, know that this non-consent trial was going to happen and to let people know that there are opportunities to opt out of the trial.

And just for full disclosure we at NWABR are planning to host a Community Conversation that Harborview will support to discuss the issues around such a non-consent trial.

In my opinion this article was not particularly balanced. It had an inflammatory headline. It compared human research subjects to lab rats, it had a paragraph that links this study to other non-related studies where research subjects died at higher rates, it inferred that researchers don’t care about consent and it also drew negative conclusions from Dr. Bulger’s previous research.

If I was a researcher I would not want to wake up to this article.

However, if you then dive into the murky world of the comments section you see that there is a sector of society who really really really distrusts science, scientists, research and everything involved in the process. The comments in relation to this article mentioned Nazi’s twice, the Medical Mafia several times, the words “creepy”, “violence”, “forced”, “tortured”, “dangerous”, “obscene”, “self-aggrandizement”, “violation” and “killing”.

The professionals involved were also accused of being in the pockets of drug companies, of acting like god and of doing unauthorized medical experimentation.

I know that as a general rule people who comment online in relation to newspaper articles do not reflect the broader community. But I want to make the argument that such comments among many others are driving community members to distrust our work. Given that we think this work is important, you all told me that earlier when you said that you care about research, then something has to change.

The status quo of us all playing nice, of us being incredibly competent at talking to each other and talking to funders, but not to the public, of hunkering down in the face of criticism, and never being proactive about telling the world about our research is not working. We are losing this fight.

In an article by Andrew Rich published in the Stanford Social Innovation review, he argues that the war for ideas is being clearly one by conservative groups. However, this is not because the conservative groups have more money. Rich’s research clearly shows that there are more mainstream and progressive organizations funding research and that they provide much more money for mainstream and progressive research.

So why is the war for ideas being lost so soundly by the mainstream and progressive communities?

The article suggests three things:

a. Conservative groups tend to fund operating costs rather than funding individual projects and programs. This means that the conservative researchers build capacity over time and are not so reliant on the hand to mouth existence.

b. Conservative groups are not so concerned about academic neutrality. They therefore will focus on activities that support their underlying ideology.

c. Conservative groups spend several hundred percent more on dissemination and external communications.

So this is not a political conference – and I am making no judgment calls about this big picture war of ideas. But I do think that as a research community we need to be thinking about how we battle to get our ideas out into the world. I think we can learn from this research on the nature of ideological debates to determine how we best position ourselves to get our message out.

The best idea in the world that is not disseminated and understood by the public has no power, credibility or ability to make change. The worst ideas out there can do unceasing damage if we can’t immediately respond and debunk the same. Just think “Death Panels”.

This war of ideas plays out in our everyday lives.

As an example I have recently had discussions with people who are opposed to immunizations. These people did not believe in immunizations and when we present data that shows the compelling evidence about the importance of immunizations both to individuals and also to the wider community they say “we don’t trust western science”.

I want to be clear these are not dumb people. I also want to acknowledge that there is room for discussion about immunizations, about efficacy, about whether some immunizations are more important than others. However, the irrational belief that western science cannot be trusted is so blatantly unfounded that it leaves no room to even start such discussions.

Within the IRB world we have become incredibly good at ensuring that our processes for approving protocols are robust, solid, and that the needs of human research subjects are taken into account. What we have not been as good at is ensuring that the general public knows that once an IRB has approved a protocol that needs of human research subjects have been addressed front and center.

What we have not been so good at is ensuring the general public understands that the science generated by this research is also robust and is on a daily basis changing our care and improving our lives. What we have not been so good at is showing how ludicrous the anti-science movement is. By trying to be humble and neutral we have allowed a fertile ground for anti-science to proliferate.

This sermon is obviously well beyond the bounds of an IRB conference, and is also somewhat wasted on the choir as I know that you all know this. So to choral this back to the topic wouldn’t it be good if an IRB approval was up there with the Good Housekeeping Seal of Approval. Slide 11.

If I was a community member on an IRB I would want it to be known that my work had made research better for the community. So how do we achieve this Nirvana. Firstly, we have to collectively come out of the closet. We have to tell the world, within the constraints of commercial secrets, what we are doing. We need to share the successes and failures in our research and our research design. We need to make strides to take our work out to the diverse communities where our work has real meaning. We need to be able to articulate this incredibly complex science in ways that translate to the general public.

We have to unabashedly promote ourselves. We need to tell our stories again and again and again.These are the necessary steps to build and to rebuild public trust. Trust requires openness, honesty, personal connections, listening, understanding and reciprocity. I think that these are all values that we can ascribe to.

Today’s conference has been set up with many of these ideas at the front of our mind. Our keynote speaker who will immediately follow me, Dr. Deborah Bowen will talk about the complexity of involving stakeholders, particularly diverse stakeholders, in the research process.

We have also planned three streams broadly called Basic, Research and Regulatory. The Basic stream is designed for people who are new to the IRB world and need to come up to speed as to why we do all of this work. The Research stream is aimed at researchers who work with IRBs so that they can understand the processes, and negotiate the highways and byways of IRB approval, ethics and communication. The Regulatory stream is for those staff who work to keep IRBs on the straight and narrow.

We, the staff, volunteers and Board at NWABR hope that you enjoy this conference. If we can do things to improve it then please tell us. As previously mentioned the IRB component of this conference will now be an annual activity so we need your feedback so that we can keep the content relevant and developmental.

I also need to formally thank you all for being here. I want to thank our co-host OHRP and our major sponsors Quorum Review, Juuva and the CITI Program at the University of Miami.